CClinicalTrials.gg
Sign In
CompletedNCT01779206ADAPTUpdated Apr 8, 2025

ADAPT - Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer

A Phase 2/3 interventional study of Epirubicin and Cyclophosphamide in Breast Cancer, sponsored by West German Study Group. Completed at 2 sites in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by West German Study Group · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled May 2012, registered Jan 2013).
Phase
Phase 2/3
Study type
Interventional
Enrollment
4,936
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Trial for the optimization of risk assessment and therapy success prediction in patients with early breast cancer by the use of biomarkers in advance to therapy decision-making to personalize therapies.

02

Conditions studied

  • Breast Cancer

Browse trials for

03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 4,936 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

West German Study Group is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)
  • Histologically confirmed unilateral primary invasive carcinoma of the breast
  • Clinical T1 - T4 (except inflammatory breast cancer)
  • All clinical N (cN)
  • No clinical evidence for distant metastasis (M0)
  • Known HR status and HER2 status (local pathology)
  • Tumor block available for central pathology review
  • Performance Status ECOG \<= 1 or KI >= 80%
  • Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients
  • Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
  • The patient must be accessible for treatment and follow-up

Additional Inclusion criteria for patients receiving chemotherapy:

  • Laboratory requirements for patients receiving neoadjuvant chemotherapy (within 14 days prior to induction treatment):

    • Leucocytes >= 3.5 x 10\^9/L
    • Platelets >= 100 x 10\^9/L
    • Hemoglobin >= 10 g/dL
    • Total bilirubin \<= 1 x ULN
    • ASAT (SGOT) and ALAT (SGPT) \<= 2.5 x UNL
    • Creatinine \<= 175 µmol/L (2 mg/dl)
  • LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to induction treatment)

Exclusion criteria

Exclusion Criteria:

  • Known hypersensitivity reaction to the compounds or incorporated substances
  • Prior malignancy with a disease-free survival of \< 10 years, except curatively treated basalioma of the skin or pTis of the cervix uteri
  • Non-operable breast cancer including inflammatory breast cancer
  • Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
  • Concurrent treatment with other experimental drugs. Participation in another interventional clinical trial with or without any investigational not marketed drug within 30 days prior to study entry
  • Male breast cancer
  • Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
  • Breast feeding woman
  • Sequential breast cancer
  • Reasons indicating risk of poor compliance
  • Patients not able to consent

Additional Exclusion Criteria for patients receiving chemotherapy:

  • Known polyneuropathy ≥ grade 2
  • Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including acute cystitis and ischuria and chronic kidney disease
  • Uncompensated cardiac function

  • Inadequate organ function including:

    • Leucocytes \< 3.5 x 10\^9/l
    • Platelets \< 100 x 10\^9/l
    • Bilirubin above normal limits
    • Alkaline phosphatase >= 5 x UNL
    • ASAT and/or ALAT associated with AP > 2.5 x UNL
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,936 participants (estimated)

Study arms

  • Active comparator
    Anthracycline - Taxane

    Study sites can choose between either Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q3w OR Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q2w for anthracycline treatment and between either 4 x Docetaxel (100mg/m²) q3w OR 12 x Paclitaxel (80mg/m²) q1w for taxane treatment.

    Drug: Epirubicin · Drug: Cyclophosphamide · Drug: Docetaxel · Drug: Paclitaxel

  • Experimental
    Taxane - Anthracycline

    Study sites can choose between either Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q3w OR Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q2w for anthracycline treatment and between either 4 x Docetaxel (100mg/m²) q3w OR 12 x Paclitaxel (80mg/m²) q1w for taxane treatment.

    Drug: Epirubicin · Drug: Cyclophosphamide · Drug: Docetaxel · Drug: Paclitaxel

Interventions

  • DrugEpirubicin
  • DrugCyclophosphamide
  • DrugDocetaxel
  • DrugPaclitaxel
06

What researchers measure

Primary outcomes

  1. Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11

    Time frame: 3 Years

Secondary outcomes

  1. Overall survival

    Time frame: 3 Years

07

Study locations

2 sites
  • Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern
    Munich, Bavaria 81377, Germany
  • Ev. Krankenhaus Bethesda Brustzentrum Niederrhein
    Mönchengladbach, NRW 41061, Germany
08

References and documents

Publications

  • Hofmann D, Nitz U, Gluz O, Kates RE, Schinkoethe T, Staib P, Harbeck N. WSG ADAPT - adjuvant dynamic marker-adjusted personalized therapy trial optimizing risk assessment and therapy response prediction in early breast cancer: study protocol for a prospective, multi-center, controlled, non-blinded, randomized, investigator initiated phase II/III trial. Trials. 2013 Aug 19;14:261. doi: 10.1186/1745-6215-14-261. PubMed 23958221 ↗
  • Nitz UA, Gluz O, Kummel S, Christgen M, Braun M, Aktas B, Ludtke-Heckenkamp K, Forstbauer H, Grischke EM, Schumacher C, Darsow M, Krauss K, Nuding B, Thill M, Potenberg J, Uleer C, Warm M, Fischer HH, Malter W, Hauptmann M, Kates RE, Graser M, Wurstlein R, Shak S, Baehner F, Kreipe HH, Harbeck N. Endocrine Therapy Response and 21-Gene Expression Assay for Therapy Guidance in HR+/HER2- Early Breast Cancer. J Clin Oncol. 2022 Aug 10;40(23):2557-2567. doi: 10.1200/JCO.21.02759. Epub 2022 Apr 11. PubMed 35404683 ↗
  • Graeser M, Schrading S, Gluz O, Strobel K, Herzog C, Umutlu L, Frydrychowicz A, Rjosk-Dendorfer D, Wurstlein R, Culemann R, Eulenburg C, Adams J, Nitzsche H, Prange A, Kummel S, Grischke EM, Forstbauer H, Braun M, Potenberg J, von Schumann R, Aktas B, Kolberg-Liedtke C, Harbeck N, Kuhl CK, Nitz U. Magnetic resonance imaging and ultrasound for prediction of residual tumor size in early breast cancer within the ADAPT subtrials. Breast Cancer Res. 2021 Mar 18;23(1):36. doi: 10.1186/s13058-021-01413-y. PubMed 33736679 ↗
  • Nitz U, Gluz O, Kreipe HH, Christgen M, Kuemmel S, Baehner FL, Shak S, Aktas B, Braun M, Ludtke-Heckenkamp K, Forstbauer H, Grischke EM, Nuding B, Darsow M, Schumacher C, Krauss K, Malter W, Thill M, Warm M, Wuerstlein R, Kates RE, Harbeck N. The run-in phase of the prospective WSG-ADAPT HR+/HER2- trial demonstrates the feasibility of a study design combining static and dynamic biomarker assessments for individualized therapy in early breast cancer. Ther Adv Med Oncol. 2020 Nov 23;12:1758835920973130. doi: 10.1177/1758835920973130. eCollection 2020. PubMed 33281950 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01779206
Lead sponsor
West German Study Group
Responsible party
Sponsor
First posted
Jan 30, 2013
Start date
May 2012
Primary completion
Sep 2019
Completion
Jan 15, 2025
Last update
Apr 8, 2025

Study contacts

Nadia Harbeck, Prof. Dr.
principal investigator · Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Germany
Ulrike Nitz, Prof. Dr.
study chair · Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms→

Other studies from this sponsor

West German Study Group

Start the discussion